VP, Medical Affairs – Provasic (RDU-90)

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The Vice President of Medical Affairs will lead the post-market scientific and technical activities for Devlin Macgregor Pharmaceuticals in preparation for the launch of Provasic. The Vice President of Medical Affairs will have overall responsibility for Medical Device Reporting / Pharmacovigilance and the Scientific Affairs group. Key areas of focus include medical education, Publications and publication planning, scientific exchange with healthcare providers and technical expertise/advice to the Company’s customers and Sales and Marketing groups. The Vice President and the Scientific Affairs group will interact directly with healthcare providers including hospital and community-based physicians, nurses and laboratory personnel. This position requires excellent scientific/medical/technical expertise, clear communication and superb management and administrative ability.

Functional Responsibilities

· Lead and manage the strategic planning, development and implementation of post-market medical/scientific/technical activities for Devlin Macgregor Pharmaceutical products (in collaboration with R&D, Sales and Marketing and Regulatory groups).
· Ensure proper training and compliance (with applicable laws and Devlin Macgregor Pharmaceutical’s policies and procedures) for all Medical Affairs personnel and consultants.
· Work with Regulatory Affairs to develop compliant (with applicable laws) procedures and processes for the Medical Affairs dept. and consultants.
· Provide expert and accurate advice to Marketing on strategic/tactical plans, materials and programs based on technical knowledge of the Company’s products and medical/scientific knowledge of disease states.
· Provide expert and accurate advice to field-based Sales personnel and customers about disease state and Devlin Macgregor Pharmaceutical, device, and diagnostic products; includes visits to customer sites.
· Provide expert and accurate advice in evaluation of new products.
· Help define and manage regional on-label medical educational programs including an expert Speakers Bureau (which reports to Medical Affairs); includes training of speakers on content and compliance.
· Evaluate and manage requests for unrestricted educational grants.
· Evaluate and manage unsolicited requests for peer-reviewed literature and off-label questions (includes periodic evaluation and categorization of the literature).
· Evaluate and manage requests for Investigator Initiated trials.
· Help develop and manage KOL network.
· Assist in product complaint investigations as appropriate.
· Other duties as appropriate to the Medical Affairs group
· Develop and implement a publication plan for all Devlin Macgregor products. This includes leading the publication committee and internal communication of the status of all publications, strategy, and overall plan.
· Develop and lead regional and national medical advisory boards.
· Develop and manage standard medical information response letters for all Devlin Macgregor products. This also includes insuring compliance with all regulations associated with medical information requests and responses.
· Manage pharmacovigilance and Medical Device Reporting requirements for all Devlin Macgregor products. This also includes managing adverse event reporting and the product complaint process and ensuring compliance with all associated regulatory requirements.

Preferred Qualifications & Experience

· MD, PhD or PharmD
· 15+ years of related industry experience in medical affairs within the pharmaceutical industry
· Demonstrated track record of successful product launches.
· Ability to lead business and technical discussions internally and externally and explain scientific/medical concepts to all levels.
· Working knowledge of current legal and promotional regulatory requirements as it pertains to medical affairs deliverables.
· Operational heft and experience building a medical affairs team and infrastructure.
· Strong understanding of how to optimize development of a drug for commercialization based upon unmet medical needs and asset value.
· Ability to cultivate and maintain relationships with key opinion leaders in the relevant fields.
· Ability to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through on requests from key opinion leaders.
· Strong leadership and management skills.


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